Capture-P Indicator Red Cells 0066240

GUDID 10888234001256

Capture-P Indicator Red Cells are part of both the Capture-P and Capture-P Ready-Screen tests, and they are used to visualize the final reaction.

IMMUCOR, INC.

Human platelet antigen (HPA) multiple antibody screening/identification IVD, kit, agglutination

• Primary Device ID: 10888234001256
• NIH Device Record Key: 52dccf71-9b11-4af7-9b40-86fbbfe72b76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Capture-P Indicator Red Cells
• Version Model Number: 0066240
• Catalog Number: 0066240
• Company DUNS: 061446282
• Company Name: IMMUCOR, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 1-855-466-8267
• Email: tech_support@immucor.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 1 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	10888234001256 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• BK860017

FDA Product Code

• KSS: Supplies, Blood-Bank

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-04-14

On-Brand Devices [Capture-P Indicator Red Cells]

• 10888234001256: Capture-P Indicator Red Cells are part of both the Capture-P and Capture-P Ready-Screen tests, a
• 10888234002314: Anti-IgG coated Indicator Red Cells are intended for use in Capture-P and Capture-P Ready-Screen